Real-World Evidence

Accessing hospital data to inform market validation, expanded labeling and post market surveillance.
The Food and Drug Administration’s program on utilization of real-world data (RWD) and real-world evidence (RWE) provides a unique opportunity to support a significant unmet need for pediatric device labeling.

Many device manufacturers cite the cost and length of pediatric-specific clinical trials as being overly burdensome to support an FDA marketing application for pediatric labeling. Therefore, the ability to collect RWD to generate RWE is critical to supporting both pediatric device development and pediatric labeling.

The MPDC has the infrastructure and experience to design, collect, and analyze RWD to generate RWE across a large multi-institutional collaborative network, through retrospective or prospective studies, to support device development and labeling from conceptualization to pre-marketing approval, and to post-marketing surveillance.
Market Validation
Off Label Expansion
Post Market Surveillance

NESTcc

In 2016, the FDA awarded a grant for the NEST Coordinating Center (NESTcc) to the Medical Device Innovation Consortium (MDIC). MDIC is a 501(c)(3) public-private partnership with the objective of advancing approaches that promote patient access to innovative medical technologies. They are committed to transforming the way medical device technologies are tested, approved and monitored.

FNIH – Pediatric Medical Devices

For years, advancement in pediatric medical devices has fallen significantly behind the rates of creation and distribution of adult medical devices. Many programs have been created to help increase pediatric medical device exposure. The FNIH will design a full-scale public-private partnership (PPP), bringing together the resources of multiple U.S. government agencies and private sector organizations.

Want to learn more about the work of the MPDC? Contact us today!
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